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The study shows that rimonabant weight, blood sugar levels and other cardiometabolic risk factors in patients with type 2 diabetes significantly improved
    Sanofi-aventis announced today that the results of the RIO-Diabetes trial were published in the online edition of The Lancet (the publication in the print edition is expected shortly). The one-year study showed that once-daily administration of 20 mg of rimonabant several cardiometabolic risk factors, including weight, HbA1c (a measure of blood sugar control), HDL cholesterol (the good cholesterol) and triglycerides (fats in the blood), systolic blood pressure and waist circumference (a marker of intra-abdominal adiposity) included, was significantly lower in overweight / obese patients with non-metformin or sulfonylurea controlled type 2 diabetes. It is particularly important that over 50% of the improvements in the parameters HbA1c and HDL-cholesterol were achieved regardless of the weight loss, suggesting a direct effect of rimonabant on these parameters.
    "The RIO-Diabetes study showed that rimonabant 20 mg provided significant improvements in weight, blood sugar levels and other cardiometabolic risk factors in the treatment of type 2 diabetes of meaning, led," said Professor André Scheen, Head of the Clinical Pharmacology, Department of Diabetes, Nutrition and Metabolic Diseases, University Hospital Liège, University of Liège, Belgium, principal investigator of the RIO-Diabetes study and a member of the RIO program steering committee. "The improved blood sugar control plus weight loss that was achieved with rimonabant is very encouraging. Most drugs used today for type 2 diabetes are associated with weight gain, and diabetes falls losing weight and maintaining the reduced weight heavy."
    Taking into account all included in the RIO-Diabetes study patients was found for those with rimonabant 20 mg once daily for patients HbA1c reduction of 0.6% compared to an increase of 0.1% in the placebo group compared with a baseline of 7.3% and 7.2% respectively (p <0.0001 vs. placebo). In the group of patients with a higher HbA1c (> 8%) could rimonabant 20 mg once daily achieved a reduction of 1.1%, compared with a reduction of 0.3% in the placebo group. Almost 70% of the 20 mg once daily treated with rimonabant patients were able to reduce their HbA1c levels to below 7%, compared to only 48% of patients in the Placeboarms (p <0.0001). Even more impressive was that 43% of 20 mg once daily for patients treated with rimonabant HbA1c levels <6.5% had at their last visit, compared to only 21% in the placebo group (p <0.0001). According to calculations, about 57% of the reduction achieved by the administration of rimonabant 20 mg once daily in HbA1c levels were achieved regardless of the weight loss. The direct peripheral metabolic effects of rimonabant on other cardiometabolic risk factors were detected throughout the RIO clinical trial program. [2,3,4]
    "These results are even more significant because they show that rimonabant was able to achieve a reduction in blood glucose levels in a patient population in which an improved adjustment or further lowering of blood sugar often is very difficult. This is very important because with each decrease HbA1c by 1% a reduction of any diabetes-related endpoint is associated by 21%, "said Professor Scheen. [5]
    Patients treated with rimonabant 20 mg once daily benefited from a weight reduction of 5.3 kg (11.7 lbs) compared to 1.4 kg (3 lbs) in patients in the placebo group (p <0.001 vs. Placebo). Waist circumference was (2.05 in) reduced in patients the rimonabant 20mg group by 5.2 cm compared to 1.9 cm (0.7 in) in the placebo group (p <0.001).
    HDL-cholesterol and triglyceride levels were improved during the study period of one year at 20 mg once daily patients treated with rimonabant. Taking into account all included in the RIO-Diabetes study patients, an increase in HDL cholesterol of 15.4% was found in the treated with rimonabant 20 mg once daily group compared to 7.1% in the placebo group (p <0, 0001). In addition, triglyceride levels (placebo, p <0.0001 vs..) Were reduced by 9.1% when treated with rimonabant 20 mg once daily for patients while they rose by 7.3% in the placebo group. Approximately 57% of the growth achieved in HDL cholesterol could not be explained by weight loss alone and was therefore an expression of a direct effect of rimonabant considered (p <0.0001).
    Rimonabant is the first selective CB1 receptor blocker, which helps reduce overactivity of the endocannabinoid system (ECS) newly described. The CB1 receptors are part of the ECS and are found centrally in the brain and peripherally in Fettgebewebe, liver, skeletal muscle, pancreas, and the gastrointestinal tract. It was shown that the ECS plays an important role in energy balance and directly on fat and sugar metabolism is involved. [6] In the periphery, overactivation of the endocannabinoid system promotes fat accumulation on Fettgewebsebene and reduces glucose uptake in skeletal muscle, which develop the may have insulin resistance and impaired glucose tolerance resulted. By blockade of CB1 receptors in the brain and in peripheral tissues rimonabant leads to a reduction in food intake, weight loss and to direct improvements in cardiometabolic risk factors, such as blood glucose, HDL-cholesterol and triglycerides.
    The RIO-Diabetes study also examined the safety and tolerability of rimonabant 20 mg once daily, 5 mg once daily and placebo, the results obtained were consistent with the data from the entire RIO clinical trial program which involved the more than 6,600 patients . Side effects were generally geringgradig, transient and self-limiting and occurred at the beginning of the treatment phase. The most commonly observed side effects included nausea (12.1% for rimonabant 20 mg once daily vs.. 5.7% for placebo), dizziness (9.1% for rimonabant 20 mg once daily vs.. 4.9% for placebo) , diarrhea (7.4% for rimonabant 20 mg daily vs. once. 6.6% for placebo), vomiting (5.9% for rimonabant 20 mg once daily vs.. 2.3% for placebo), self-reported hypoglycemia (5, 3% for rimonabant 20 mg daily vs. once. 1.7% for placebo), fatigue (5.3% for rimonabant 20 mg once daily vs.. 3.7% for placebo) and anxiety (5.0% for rimonabant 20 mg once daily vs. 2.6% for placebo). The rates of discontinuation due to adverse events were consistent with those reported in other studies in the RIO program rates (15% for rimonabant 20 mg once daily vs.. 5% for placebo, p <0.005). The most commonly leading to discontinuation adverse events were depressive disorders, nausea and dizziness.
    Sanofi-aventis was notified the U.S. Food and Drug Administration to grant approval of rimonabant in February 2006. In Europe, rimonabant, there under the name Acomplia (R), as an adjunct to diet and physical exercise in the treatment of obese patients (BMI greater than or equal to 30kg/m2), or overweight patients (BMI> 27kg/m2) with associated risk factors such as type 2 diabetes or dyslipidaemia admitted.
    Information on the RIO-Diabetes study
    In the RIO-Diabetes trial is a multinational, multicenter, randomized, double-blind, placebo-controlled phase III study in which two fixed doses of rimonabant (5 mg once daily and 20 mg once daily) with placebo over a period one year were compared. The study was conducted on 1,047 type 2 diabetic patients in 159 centers in 11 countries. The study participants were men and women between 18 and 70 years of age who had a BMI between 27 kg/m2 and 40 kg/m2. To the additional criteria included an HbA1c levels between 6.5% and 10% and a fasting glucose level between 5.5 mmol / l (100 mg / dl) and 14.9 mmol / l (270 mg / dl).
    The study was aimed to assess the efficacy and safety of rimonabant in patients with type 2 diabetes who have been treated with either metformin or sulfonylurea monotherapy. The study examined the effect of rimonabant on HbA1c and other cardiometabolic risk factors. Safety and tolerability were also evaluated over the treatment period of one year.
    The RIO-Diabetes study is one of four Phase III trials in the RIO program, examined the efficacy and safety of rimonabant for improvement of cardiometabolic risk factors and the weight loss in over 6,600 overweight and obese, the world's patients studied . All four studies - RIO-Diabetes, RIO-Lipids, RIO-Europe and RIO-North America - in the phase III program were completed.
    The results of the RIO-Diabetes study were first presented at the Annual Scientific Session of the American Diabetes Association in June 2005.
    About sanofi-aventis
    Sanofi-aventis is the third largest pharmaceutical company in the world and is located in Europe in the first place. Thanks to its R & D organization, sanofi-aventis is building world-class leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
    Forward-looking statements
    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by words such as "expect," "anticipate," "believe," "intend," "estimate," "plan," or similar expressions. Although the management of sanofi-aventis believes that such forward-looking statements contained herein are reasonable, investors are cautioned that forward-looking information and statements to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis. This could cause actual results and developments to differ materially from those expressed in the forward-looking information and statements, implied or predicted by these. These risks and uncertainties include those discussed in the investments made by sanofi-aventis public filings with the SEC and the AMF or discussed, including those risks and uncertainties set forth under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended 31 Were made in December 2005 ended year. On the applicable law, sanofi-aventis no obligation to update any forward-looking information or statements or to revise.
    Literature:
    [1] Scheen et al. Effect and tolerability of rimonabant in overweight or obese patients with type 2 diabetes: a randomized controlled study. The Lancet, 2006.
    [2] Van Gaal et al. Effects of the cannabinoid-1 receptor blocker rimonabant on weight reduction and cardiovascular risk factors in overweight patients: 1-year experience from the RIO-Europe study. The Lancet 2005, 365: 1389-97.
    [3] Despres J-P., A. Golay, Sjostrom L, et al. Effects of rimonabant on metabolic risk factors in overweight patients with dyslipidemia. New Engl J Med 2005, 353: 2121-34.
    [4] Pi-Sunyer X, et al. Effect of rimonabant, a cannabinoid-1 receptor blocker, on weight and cardiometabolic risk factors in overweight or obese patients RIO-North America: A Randomized Controlled Trial. JAMA 2006, 295: 761-775.
    [5] Stratton IM, Adler AI, Neil HA, Matthews DR, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000; 321:405-12.
    [6] Di Marzo V, Matias I, et al. Endocannabinoid control of food intake and energy balance. Nat Neurosci 2005; 8:585-9.

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